BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPRIME EXTENSION SET

    MDR report key: 402392 · Received June 28, 2002

    Report

    Report Number
    1526863-2002-00063
    Event Type
    Injury
    Date Received
    June 28, 2002
    Date of Event
    May 17, 2002
    Report Date
    May 30, 2002
    Manufacturer
    MEDEX
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE FEMALE LUER LOCK IS CONNECTED TO A MANIFOLD. 30% GLUCOSE WAS GIVEN THROUGH THE MX597. AFTER ONE OR TWO TIMES DISCONNECTING AND RECONNECTING THE LINE, CRACKS IN THE FEMALE LUER LOCK OCCURRED AND START TO LEAK. THE NEONATE RECEIVED TOO LITTLE FLUID (=GLUCOSE 30% IN THE CASE) WHICH CAN UNDER CERTAIN CIRCUMSTANCES CAUSE BRAIN DAMAGE, HOWEVER THERE IS NO DATE TO SUPPORT THIS AT THIS TIME. THIS WAS REPORTED BY MAXXIM MEDICAL EUROPE BV TO MEDEX MEDICAL UK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPRIME EXTENSION SET FLUID ADMINISTRATION SET FPA MEDEX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention